510(k) Report

Devices descending from K884930

293 later devices reach Compax Model 40, 400, 400T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K18234814HK701G-WLg Electronics.Inc20187—
+6K181631GR40CWSamsung Electronics Co., Ltd.20185—
+6K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+6K18033217HK700G-WLg Electronics20188—
+6K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+6K173517RADspeed fitShimadzu Corporation20181—
+6K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+6K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation20173—
+6K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+6K160997GC85ASamsung Electronics Co., Ltd.201626—
+6K153401GR40CWSamsung Electronics Co., Ltd.201520—
+6K152788EOS SystemEos Imaging20153—
+6K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+6K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+6K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+6K132847I2CIon Beam Applications S.A.201303
+6K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20133—
+6K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed201315—
+6K122736DX-D Imaging PackageAgfa Healthcare N.V.201325—
+6K122865Vivix-S WirelessVieworks Co., Ltd.201328—
+6K122866Vivix-S with VxvueVieworks Co., Ltd.201311—
+6K121095DX-D Imaging PackageAgfa Healthcare N.V.20123—
+6K121513Multix FusionSiemens Medical Solution2012324
+6K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+6K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+6K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+6K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+6K103597DX-D 100Agfa Healthcare N.V.201116
+6K103050DX-D 300Agfa Healthcare N.V.20108—
+6K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+6K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+6K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+6K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+6K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+6K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+6K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+7K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+7K252133Adaptix Ortho350Adaptix Limited20250—
+7K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+7K223842DRX - CompassCarestream Health, Inc.20231—
+7K22146110HQ701G-BLg Electronics.Inc20220—
+7K22139414HQ701G-BLg Electronics.Inc20221—
+7K22143417HQ701G-BLg Electronics.Inc20220—
+7K220175GM85Samsung Electronics Co., Ltd.20223—
+7K220518Skanrad 400Skanray Technologies Limited20220—
+7K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+7K203188ADDH&abyz Co., Ltd.20213—
+7K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+7K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—
+7K192079EOSedgeEos Imaging20192—
+7K191504PowerDRRadiology Information Systems, Inc.20190—
+7K191884DR 100sAgfa N.V.20190—
+7K191877FLUOROspeedShimadzu Corporation201902
+7K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+7K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+7K18328617HK701G-WLg Electronics.Inc20182—
+7K181789VeriSuiteMedcom GmbH20180—
+7K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+7K172229GC85ASamsung Electronics Co., Ltd.201721—
+7K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+7K171119GM85Samsung Electronics Co., Ltd.2017221
+7K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+7K162344Innolux RicInnolux Corporation20161—
+7K163115GC70Samsung Electronics Co., Ltd.201623—
+7K161019Uroview FDPausch Medical GmbH201621
+7K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+7K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+7K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+7K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+7K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+7K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+7K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.201512—
+7K150663Diagnostic X-ray SystemOsko, Inc.20150—
+7K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+7K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+7K141602DX-D Imaging PackageAgfa Healthcare N.V.20140—
+7K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+7K141192DR 400Agfa Healthcare N.V.20147—
+7K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH201415—
+7K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+7K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+7K122768GenesisDornier Medtech America, Inc.20134—
+7K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+7K113855Panorad, Panorad SLImix Adr Finland OY20120—
+7K112670DX-D 600Agfa Healthcare N.V.201174
+7K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+7K101042BladeviewAccogent, LLC20100—
+7K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+8K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+8K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+8K223550DMXDel Medical, Inc.20230—
+8K22354614HQ721G-BLg Electronics.Inc20230—
+8K221281Multitom RaxSiemens Medical Solutions202201